From: Joyce and Herbert Stein [mailto:firstname.lastname@example.org]
Sent: Monday, August 19, 2013 2:10 AM
To: Kathleen Sebelius
Subject: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients…
Dear Ms. Sebelius,
Can you please help us?
As a brief summary we have a very serious and potentially life-threatening situation. My spouse Joyce volunteered and contracted to be a volunteer medical study subject for the newest neuro-modulation implantable therapy for depression at the time. VNS Therapy (Vagus Nerve Stimulation) sponsored by Cyberonics Inc. The indication was FDA approved which then relinquished the sponsor of any further responsibility for patient medical care. The indication was later denied by CMS (Centers for Medicare and Medicaid Services) in a national determination document. The therapy has proven remarkably beneficial for my spouse and other study subjects as well as a number of patients who were able to acquire the device through Medicare/Medicaid during the brief window of opportunity between FDA approval and subsequent CMS denial. Despite having our own health insurance through a United Healthcare Advantage PPO we all cannot obtain insurance reimbursement for care, services or replacement for this indication.
I will also point out to you the very same therapy is FDA and CMS approved for epilepsy.
In the egregious and serious oversight CMS did not consider, provide or grandfather care for this small group of patients who are for years doing well. In turn these patients are saving Medicare/Medicaid tens of thousands of dollars yearly in hospitalization, medical, medication, doctor etc. costs as a result of their wellness and now face returning to “The Black Hole” from which they emerged after decades of suffering and anguish as well as suicide attempts. This small group of study subjects (my spouse Joyce included) and other patients implanted with the device are doing well and want to continue with the therapy and will need replacement when their batteries deplete. They are being denied medical care and health insurance coverage by CMS, private health insurance carriers and Cyberonics. The cost for replacement of the device is financially prohibitive for most patients.
I also bring to your attention that early on I became aware of this possible oversight and loophole. I communicated my concerns to the sponsor (Cyberonics). The whole story I hope is clearly covered in my petition listed below with reference links to information and documents. One such document was issued by Cyberonics (Lifetime Reimbursement Guarantee) which I’ve also attached. Cyberonics has reneged on this guarantee. The current CEO, Dan Moore cited “kickback statue” which I strongly opine is a sham excuse.
To also help humanize us and especially my spouse Joyce I would like to share with you and/or your colleagues one of a number of YouTube uploads of Joyce relating to VNS Therapy. We just recently celebrated our 50th Wedding Anniversary on August 10, 2013.
We are real flesh and blood people and not just numbers as we live our lives independently as best we can and deal with life’s challenges as they confront us. We struggled for some 36 years with Joyce’s major depressive illness and 9 suicide attempts. 14 years ago VNS turned her life around and has given both of us a life. We don’t want to go back there least of all because someone screwed up through no fault of our own.
I am asking or really pleading for your help whether it be you or someone else in authority to understand our plight to make a compassionate dispensation or whatever appropriate terminology you folks use to see that these people maintain their wellness and stay off the public dole.
Please feel free to contact me any time, day or night, as I am working with little sleep trying to get our message heard and acted upon responsibly and compassionately. I’ll welcome any questions or concerns you may have.
Lastly, please confirm receipt of this communication. Thank you.
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
VNS THERAPY FOR DEPRESSION (VAGUS NERVE STIMULATION)
The purpose of this petition is quite simple and straight forward, that is to obtain medical care and/or health insurance coverage for a group of volunteer medical study subjects for an FDA (Food and Drug Administration) approved therapy and to warn all medical volunteer study subjects to obtain in writing who is responsible for their medical care if CMS (Centers for Medicare and Medicaid Services) and/or one’s own insurance company denies coverage.
FDA approval does not mean or insure medical care or health insurance coverage.
On or about 1997 Cyberonics, Inc. received FDA approval for VNS Therapy for Epilepsy. On or about 1998 Cyberonics additionally got the go ahead to institute an open pilot study (D-01) for the same VNS Therapy for Depression. The D-01 was instituted as a result of Epilepsy studies and patients not only reporting decreases in number and severity of their seizure activity but also diminishing depression episodes.
Through the assistance and caring of my spouse’s then attending psychiatrist, Dr. Paul Goodnick, Joyce was enrolled in the D-01 open study as study subject #46 at MUSC (Medical University of South Carolina) under the directorship of Dr. Mark George and Dr. Ziad Nahas. She was implanted with the device on December 13, 1999.
In our desperation at the time and after some 36 years of Joyce’s continuing severe depressive episodes and suicidal attempts and failed therapy trials as well as numerous ineffective medications and refractory treatments, she signed the papers for this newest neuro-modulation study.
We carefully noted that death was a possible outcome. We also noted once FDA approved, Cyberonics would no longer be responsible for her medical care.
What we didn’t know or realize at the time of signing nor did any of the study volunteers and worse yet the fact that all the other affiliated parties and medical professionals didn’t take into consideration when structuring any of these depression studies that with FDA approval it ended Cyberonics responsibility for medical care but it did not insure Medicare/Medicaid and/or health insurance coverage for the study subjects. Nor did anyone know despite FDA approval that CMS would deny coverage for this medical device (historically the first time such an event took place) left these volunteer patients in a Catch-22 with an implanted medical device and no one willing or responsible to pay for medical care despite some of the study subjects with paid up health insurance but still denied coverage for this particular therapy.
VNS Therapy, VNS depression studies, Cyberonics, the former CEO Robert P. (“Skip”) Cummins and the FDA have all been steeped in controversy and maligned as well. Yet and at the time, when I brought this loophole to the attention of Mr. Cummins he assured me “not to worry.”
Mr. Cummins honored his words and to his credit, took action and made a responsible and morally correct pronouncement. He acted and assured the depression study subjects would have health coverage for the VNS Therapy if their own health insurance and/or Medicare/Medicaid carriers denied to cover the therapy by publicly announcing on January 18, 2006:
“Lifetime Reimbursement Guarantee for All TRD IDE Study Patients and $15 Million TRD Indigent Care Program…Cyberonics has taken the unprecedented steps with its lifetime reimbursement guarantee for study patients and its $15 million TRD Indigent Access Program, to ensure that study patients and indigent Americans with TRD have fully informed access to VNS Therapy.”
Similar information was also entered into the Cyberonics corporate 8-K SEC filings.
Mr. Skip Cummins is no longer with Cyberonics and the current management has reneged upon their oral and published contract, commitments and statements. The company has refused to pay for the servicing, care and replacement of their implantable devices for those volunteer study subjects (patients) wanting to continue the therapy.
A number of these volunteers, who were devastatingly ill, are benefiting long-term and living reasonable quality of lives as a result of VNS Therapy. These patients are being denied health insurance coverage by their own paid for carriers as well as Medicare/Medicaid despite the fact the therapy works for them and was FDA approved.
Adding to the illogic of this conundrum is the fact the very same therapy is covered by Medicare/Medicaid and health insurance carriers for epilepsy and that some 200 leading psychiatric professionals had commented during the write-in period to CMS that the therapy should be approved for coverage based upon their personal patient treatment experiences and that conventional therapies are ineffective for this unique population of seriously ill patients.
In the infinite “lack” of wisdom on the part of our government’s convoluted working agencies to protect us the FDA, CMS as well as the sponsor and the oath taken by all the medical researchers (to do no harm) no one thought to ask or provide for health care and replacement coverage for these medical volunteers. Thereby leaving these study subjects (my spouse included) with a costly implanted medical device and therapy that no study subject rightfully or morally should be paying for out-of-pocket especially since we have health insurance.
CMS in their denial of coverage should have rightfully grandfathered in the existing study subjects. They did not.
One last and most important point; Joyce and I still remain advocates for VNS Therapy for Depression as a potentially viable treatment option to be considered by a reasonably informed patient.
As a result of this therapy my spouse has been depression free approaching 14 years. We no longer discuss depression. She takes no antidepressants. Our major concern is to continue maintaining her past 14 year wellness utilizing the same VNS Therapy and to have our paid for health insurance carrier, Cyberonics and/or any other responsible party honor their commitments to cover Joyce’s medical expenses and that of the other study subjects as they do for epilepsy.
At the same time to once again caution and make aware to other volunteer medical study subjects in any other kind of study to not get caught up in a very stressful similar and costly situation and negligent oversight.
I am requesting The United States President, Senate, Congress, CMS, state and local governmental officials, Health Insurance Industry, Cyberonics and all medical professionals especially those having anything to do with VNS Therapy for Depression to do the responsible and morally correct thing by exerting pressure upon any of the responsible parties to correct this oversight and injustice by helping these volunteer study subjects (patients) to obtain medical coverage and to insure future medical study volunteers are not faced with a similar predicament.
Thank you all for your consideration in reading this petition and joining in to obtain health care for all medical research study volunteers.
Herbert Stein, caregiver and long-time support person to my spouse, Joyce Stein
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